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New data to be presented on Bayer’s Xarelto®



Bayer HealthCare has announced that new scientific data will be presented at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, LA, USA, December 7-10, 2013. These data will provide further clinical insights for physicians and patients regarding the benefits of the novel oral anticoagulant Xarelto® (rivaroxaban) globally approved for the treatment and prevention of recurrent pulmonary embolism (PE) and deep vein thrombosis (DVT).
These analyses of the pivotal EINSTEIN Phase III data examine the results based on various patient subgroups including patients with different levels of PE severity as well as DVT and PE patients on concomitant statin therapy, offering insights that may be helpful in similar real-world clinical settings.
Notable data analyses to be presented at ASH 2013 include*:
  • Performance of the Simplified Pesi Score in Patients with Pulmonary Embolism Treated with Rivaroxaban or Standard Therapy
– Poster Session: 332. Antithrombotic Therapy: Poster I Session
– Saturday, December 7, 2013; 17.30-19:30; Hall E
  • Statin Use was Associated with a Non-Significant Reduction in the Observed Incidence of Recurrent VTE in EINSTEIN-DVT and EINSTEIN-PE
– Poster Session: 332. Antithrombotic Therapy: Poster I Session
– Saturday, December 7, 2013; 17.30-19:30; Hall E
In addition, results from a Phase II proof-of-concept study in healthy volunteers demonstrating that Portola Pharmaceuticals’ andexanet alfa provided dose-dependent and well-tolerated reversal of the anticoagulant effects of Xarelto will be presented:
  • A Phase II Randomized, Double-Blind, Placebo-Controlled Trial Demonstrating Reversal of Rivaroxaban-Induced Anticoagulation in Healthy Subjects by Andexanet Alfa (PRT064445), an Antidote for FXa Inhibitors
– Poster Session: 332. Antithrombotic Therapy: Poster III Session
– Monday, December 9, 2013; 18.00-20:00; Hall E
About the EINSTEIN Clinical Trial Programme
The pivotal EINSTEIN Clinical Trial Programme including nearly 10,000 patients comprises three Phase III studies. EINSTEIN DVT and EINSTEIN PE evaluated Xarelto alone (15mg twice daily for 21 days followed by 20mg once daily) versus the dual-drug regimen of low molecular weight heparin (LMWH) and a vitamin K antagonist (VKA) in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE. The EINSTEIN Extension study compared Xarelto with placebo for the long-term prevention of recurrent symptomatic DVT and PE in patients who previously completed 6 or 12 months of anticoagulation treatment with either VKA or Xarelto.
Xarelto is the first single-drug solution approved for the treatment of DVT and PE as well as the prevention of recurrent DVT and PE.
About Xarelto® (Rivaroxaban)
Rivaroxaban is the most broadly indicated novel oral anticoagulant and is marketed under the brand name Xarelto®. Xarelto is approved for five indications across seven distinct areas of use, protecting patients across more venous and arterial thromboembolic (VAT) conditions than any other novel oral anticoagulant:
  • The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors
  • The treatment of deep vein thrombosis (DVT) in adults
  • The treatment of pulmonary embolism (PE) in adults
  • The prevention of recurrent DVT and PE in adults
  • The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery
  • The prevention of VTE in adult patients undergoing elective knee replacement surgery
  • The prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine
Whilst licences may differ from country to country, across all indications Xarelto is approved in more than 125 countries.
Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the US by Bayer HealthCare and in the US by Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company).
Anticoagulant medicines are potent therapies used to prevent or treat serious illnesses and potentially life-threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.
Responsible use of Xarelto is a very high priority for Bayer, and the company has developed a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practice.
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